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In the dynamic and highly regulated world of pharmaceuticals, ensuring GxP (Good Practice) compliance is essential for maintaining the highest standards of product quality, safety, and efficacy. GxP compliance encompasses a comprehensive range of regulatory requirements that govern every aspect of pharmaceutical production and distribution. Join us as we explore the importance of GxP compliance […]
In the rapidly evolving world of MedTech, staying compliant with the latest regulations is more critical than ever. The updated Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) have introduced more detailed and stringent requirements, pushing many product classifications into higher-risk categories. Consequently, MedTech companies may find themselves in need of specialised knowledge […]
The recently introduced Windsor Framework discusses changes to the packaging and labelling requirements for medicinal products for human use within the UK. These changes, effective from 1 January 2025, aim to ensure that medicines destined for the UK market are clearly distinguished from those intended for the European Union (EU) market. This blog post provides […]
The medical device industry is undergoing significant regulatory changes with the transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR). These new regulations aim to enhance the safety, performance, and traceability of medical devices within the European Union. In this blog post, we will compare MDD and MDR, highlight the key […]